The present invention relates to a sterilizable flexible package for the reconstitution and administration of fluid medicinal or nutritional substances which are infused or instillable within the body of a patient, and to a process for the sterilization thereof.
Packages are known for the infusion or instillation of medicinal or nutritional products within the body of a patient, comprising a bag of liquid diluent provided with at least one outlet tube provided with a closing device, and a mixing tube provided with an openable closure and ending with a coupling and perforation device for a vial of pharmacological or nutritional substance in the form of powder, gel or other material, provided with a perforable cap. Such packages further comprise a hermetically closable, sterile, flexible casing containing the bottle of the powdered substance or other, and the coupling and perforation device.
Such packages allow the vial to be manually handled from the outside of the casing from a coupling position to the position of perforation of the cap through the coupling and perforation device, thus ensuring sterility conditions when the vial containing the powdered medicinal or nutritional substance is perforated to be connected to the mixing tube extending from the bag.
However, the current processes for sterilizing the aforesaid flexible packages imply high costs since they require the presence of suitable sterilization chambers and also involve complex steps.
GB 2 117 733 A1 discloses a package according to the preamble of claim 1.
In light of the problems above, it is the object of the present invention to provide a package of the aforesaid type, which is sterilizable by means of an innovative sterilization process which is simple and affordable.